Blood Pressure Telemonitoring and Goal Blood Pressure in Diabetes

Mayo Clinic

Status: Completed

Conditions: Hypertension; Diabetes

Treatments: Device: Home blood pressure monitor without telemetry; Device: Blood pressure monitor with telemetry

Study type: Interventional

Funder types: Other

Identifiers

NCT01300338

10-003562

Details and patient eligibility

About

Does home telemonitoring increase the number of diabetes patients at goal blood pressure in a primary care practice?

Full description

This is a randomized control trial, two arms with block randomization. Primary care patients with diabetes and elevated blood pressure randomized to intervention or control. Intervention arm: home telemonitoring using the Ideal Life blood pressure cuff and telephone or internet transmission device to transmit blood pressure information to the Primary care manager team with otherwise normal care manager care. Control arm: Omron (off the shelf) home blood pressure monitor (no transmission of data) and usual care. We will be comparing blood pressure control between groups and provider contacts.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-75 (inclusive
• Blood pressure in hypertensive range (systolic >= 140 or diastolic >=90
• Diabetes

Exclusion criteria

• Pregnancy
• Lack of computer with internet access or phone line
• Lack of English language literacy
• Arm size to large or small for cuff

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Blood pressure with telemetry

Experimental group

Description:

Home blood pressure monitor with telemetry

Treatment:

Device: Blood pressure monitor with telemetry

Blood pressure without telemetry

Active Comparator group

Description:

Home blood pressure self monitor without telemetry.

Treatment:

Device: Home blood pressure monitor without telemetry